2020 - The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities

The course offers methodologies and techniques on:
Quality Agreements
The Origin and Background around Quality Agreements
When are Quality agreements appropriate?
The Scope of Quality Agreements
Quality Agreement Formatting and Content
How to negotiate a Quality agreement
DMFs
Who really needs a DMF and why?
The various types of DMFs - which is best for your products.
The relationship between DMFs and drug and biologics applications.
The symbiotic relationship between DMFs and current Good Manufacturing Practices (c-GMPs).
Common DMF errors - how to avoid them.
How to deal with deficiency letters and their origins.
Effective change control strategies.
Ramifications of inadequate preparation and/or maintenance and recent enforcement actions and inspection trends.
The conversion from paper to e-filings at FDA for Human and Veterinary Products.